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Ref: LTT165/270214/1/F

Lariam250mg Tablets

(mefloquine)

Patient Information Leaflet


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Lariam 250mg Tablets and will be referred to as Lariam throughout the rest of this leaflet.

What is in this leaflet

[4 What Lariam is and what it is used for 3 What you need to know before you take Lariam How to take Lariam [4 Possible side effects How to store Lariam

[4 Contents of the pack and other information


In a small number of patients it has been shown that dizziness and loss of balance may continue for a few months after taking Lariam.

Lariam contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.


^ What Lariam is and what it is used for

Lariam Tablets conatin the active ingredient mefloquine. They are used to treat malaria and to help prevent you from catching malaria.

Malaria is a life threatening disease and a major health risk for travellers visiting tropical countries.

It occurs when small parasites are passed from one person to another by the bites of certain mosquitoes. Lariam is especially useful if you are travelling to countries where there is a type of malaria which is particularly difficult to treat. No single medicine is effective against all malaria parasites. The choice of a particular medicine depends on the sensitivity of the malaria parasites found in the area to be visited. Your doctor will advise you whether Lariam is suitable for the area to which you wish to go.

To help minimise your chance of catching the disease and to protect you from possible serious side effects it is important that you read this leaflet carefully. Ask you doctor to explain anything you do not understand.


What you need to know before you take Lariam

Do not take Lariam:

   if you are allergic to mefloquine or any of the other ingredients of this medicine (listed in section 6) or to similar medicines such as quinine. quinidine or chloroquine

   if you have depression, thoughts about suicide and self-endangering behaviour.

   if you have any other mental problem. including anxiety disorder, schizophrenia or psychosis (losing touch with reality)

   if you have fits (seizures or convulsions)

   if you have severe liver problems

   if you have had blackwater fever (a complication of malaria that affects the blood and kidneys)

   medicines such as quinine. quinidine. or chloroquine, used to treat or to prevent malaria

   medicines for any heart trouble, or high blood pressure, such as 3-blocking agents. calcium channel blockers

   antihistamines for allergies

   medicines for some mental problems (psychiatric disorders).

Anti—depressants such as tricyclic anti—depressants. selective serotonin reuptake inhibitors (SSRIs). bupropion or anti—psychotics such as phenothiazines

   medicines used to treat epilepsy such as sodium valproate carbamazepine, phenobarbital, phenytoin

   ketoconazole (used to treat fungal infections) — you should also ask your doctor for advice before taking ketoconazole within 15 weeks after taking Lariam

   antibiotics used to treat bacterial infections for example rifampicin, penecillins. cephalosporins

   efavirenz (used to treat HIV infections)

   tramadol (used to treat severe pain)

   medicines for blood clotting disorders or diabetes, as your doctor may wish to monitor you before you travel.

If you need an oral vaccine to help prevent you from catching typhoid. you should arrange to receive it at least 3 days before you need to start taking Lariam. Otherwise Lariam may stop the vaccine from working properly

Pregnancy and breast-feeding

Pregnant women should not normally take these tablets.

It is important to tell your doctor if you are pregnant or think you could be pregnant, as she or he may decide that you should not use this medicine.

Women of child bearing age are advised to use adequate contraception whilst taking Lariam to prevent them from catching malaria and for 3 months after the last dose.

It is recommended that you do not breast-feed while you are taking these tablets.

Driving and using machines

Take special care if you perform activities requiring alertness and coordination (accurate small movements) and spatial awareness (being aware of distances) such as driving pilotong an aircraft, operating machinery and deep sea diving as Lariam can cause dizziness loss of balance and mental problems (see section 2).


rp How to take Lariam

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The advice you are given will depend on whether you are taking the tablets for prevention or treatment of malaria. Take the tablets with plenty of water and preferably after a meal. Swallow the tablets whole do not suck or chew them.

Malaria prevention

Please read the following section if you are taking the tablets to help prevent you from catching malaria.

If any of the above applies to you, make sure your doctor can prescribe a different medicine for prevention or treatment of malaria.

Also, consult your doctor immediately if you are already being treated with halofantrine, or you have been prescribed a course of halofantrine. Halofantrine (which is used to treat malaria) and Lariam taken at the same time can slow the heartbeat to a dangerous level. Therefore to help avoid the possibility of a dangerous alteration in heart rhythm you must not take halofantrine if you are already taking or have taken Lariam within the last 15 weeks.

Warnings and precautions

Lariam may cause serious mental problems in some people. Please seek medical help immediately if you experience any of the following:

   suicidal thoughts

   self-endangering behaviour

   severe anxiety

Tell your doctor if you experience any of the following:

   feelings of mistrust towards others (paranoia)

   seeing or hearing things that are not there (hallucinations)

   nightmares

   depression

   feeling restless

   unusual behaviour

   feeling confused

Talk to your doctor or pharmacist before taking Lariam if you:

   suffer from epilepsy

   have fits (seizures or convulsions)

   have heart problems. especially changes in heart rhythm

•    have liver or kidney problems

   have eye problems (eg loss of fine detail colours seem faded sudden loss of vision poor vision at night)

•    abnormal blood test showing a decrease or an increase in white blood cells or a decrease in red blood cells or platelets.

•    experience pins and needles, weakness numbness new or worsening clumsiness or unsteadiness on your feet, or shaking of the hands and fingers

•    experience fever, chills, cough, shortness of breath or chest pain. These could be signs of inflammation of the lungs also known as pneumonitis.

•    have previously contracted malaria even though you were taking Lariam tablets for malaria prevention

If you are a woman of child-bearing age you should take reliable contraceptive precautions whilst you are taking Lariam and for 3 months after the last dose.

Children

Experience with Lariam in babies less than 3 months old or weighing less than 5kg is limited.

Other medicines and Lariam

Tell youe doctor or pharmacist if you are taking have recently taken or might take any other medicines including:

•    haloflintrine. or you have been prescribed a course of halofantrine (see section 2)

Important

•    Take the tablets once a week always on the same day.

   Take the 1st dose 10 days before you leave: this is to make sure that Lariam is well tolerated.

•    Take the 2nd dose 3 days before you leave.

•    Continue taking the tablets on the same day of the week throughout your stay and for

4 weeks after your return.

•    The full course of tablets is at least 6 weeks, depending on your length of stay.

   For effective prevention you must take the full course of tablets.

   No anti-malarial tablets can be 100% guaranteed to work. There is a chance you could still get malaria during or after taking medicine to prevent it. If you develop a fever or flu-like symptoms during your travels or within 2 to 3 months after you leave the malarious area, check with a doctor immediately.


Adults and children over 45kg body weight dose:

One tablet weekly (always on the same day):


Lariam 250mg Tablets

(mefloquine)


Patient Information Leaflet (continued)

A pack of 8 tablets is enough to help prevent you from catching malaria if you are staying for 2 weeks in an area where malaria is present and you start taking the tablets at 10 days and 3 days before departure.

Adults weighing less than 45kg (99 lbs) should take the childrens dose (see below).

Whether you are an adult or a child you should not take the tablets for more than 12 months.

Children's dose:

The tablets are not recommended for children under 3 months of age, i.e., those who weigh less than 5 kg (11 lbs). For children over this weight, the dose is shown in the table below. The tablets can be divided by breaking along the score lines. As in adults, the dose should be taken once weekly on the same day, and continued for 4 weeks after return.

Weight

Age

(approx)

Dose

5-19 kg (11-42 lbs)

3 months-5 years

A tablet

20-30 kg (44-66 lbs)

6-8 years

% tablet

31-45 kg (68-99 lbs)

9-14 years

% tablet

Malaria treatment

Please read the following section if you are taking the tablets to treat malaria.

Your doctor will tell you how much medicine you need to take. This will depend on your weight and whether you have been living in a malarious area. Normally, you should not receive more than 6 tablets in total. You may be advised to split the total dose into 2 or 3 smaller doses, 6-8 hours apart, to reduce the likelihood or severity of unwanted effects.

If you take more Lariam than you should, either for prevention or treatment

If you take too many tablets the likelihood and severity of the side effects as described in section 4 may increase.

If you take too many tablets or someone else accidentally takes your medicine contact your doctor pharmacist or nearest hospital immediately.

If you forget to take Lariam, either for prevention or treatment

If you miss a dose take it as soon as possible. If it is nearly time for your next dose skip the missed dose and carry on as before. Do not take a double dose.

[4 Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience:

   attempted suicide

   suicidal thoughts

   self-endangering behaviour

   allergic reaction (anaphylaxis) with symptoms such s difficulty in breathing, swollen tongue, itching and severe rash

   severe changes in texture and appearance of the skin, especially if it affects your mouth and eyes (Stevens Johnson syndrome)

   psychosis (losing touch with reality)

   severe anxiety

   depression

   panic attacks

   fits (seizures or convulsion)

   fever, chills, cough, shortness of breath or chest pain. These could be signs of inflammation of the lungs also known as pneumonitis

•    Severe liver problems which might be demonstrated by transient increase in your liver enzymes shown by blood tests or other symptoms such as tender, firm or possibly enlarged liver, jaundice (yellowing of skin/eyes), dark urine, light coloured stools and generalised itchiness

•    Pins and needles, weakness, numbness, new or worsening clumsiness or unsteadiness on your feet or shaking of the hands and fingers

   Painful mouth or throat ulcers, fever, chills, bruises on the skin, nosebleeds, bleeding in the stomach or vaginal bleeding. These could be signs of blood disorders

Talk to your doctor if you experience:

•    feelings of mistrust towards others (paranoia)

•    seeing or hearing things that are not there (hallucinations)

•    feeling restless

•    unusual behaviour

•    feeling confused

   unusual changes in your mood

   agitation

   new or worsening feeling of anger (aggression)

   disturbance in attention

   heart problems e.g. severe changes in heartbeat, including pounding racing or skipped beats (palpitations)

Please seek medical help immediately if you experience serious mental problems while taking Lariam. Lariam should be stopped immediately and replaced with another medicine to prevent malaria.

Very common (may affect more than 1 in 10 patients):

   sleeping problems (sleepiness, unable to sleep, bad dreams)

Common (may affect up to 1 in 10 patients):

   dizziness, headache, problems with your vision, loss of balance (vertigo), feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache (abdominal pain), itching

Frequency not known (cannot be estimated from available data):

   decreased appetite, forgetfulness (sometimes lasting for more than 3 months), fainting

   difficulites in talking, cataract, blurred vision, dazzled in the evenings or other vision disturbances

   changes to your hearing including ringing in the ears or difficulty in hearing (sometimes prolonged)

   changes to blood pressure or heart rate, hot flushes, breathlessness, cough, indigestion, rash, hair loss, sweating, muscle weakness, muscle cramps, joint pains, muscle pains, oedema, chest pain, tiredness, fever or chills

Lariam can stay in the body for a long time after taking the last dose. In few people some side effects may last for a few months after they have stopped taking Lariam (e.g. dizziness, sleepiness).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/vellowcard.

By reporting side effects, you help provide more information on the safety of this medicine.


[a How to store Lariam

*    Keep out of the sight and reach of children.

*    Do not store above 30°C.

*    Store in the original package.

*    If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

*    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


Q Contents of the pack and other information

What this Lariam contains:

The active substance in Lariam is Mefloquine. Each tablet contains 250mg Mefloquine

The other ingrediens are: poloxamer 3800, microcrystalline cellulose lactose anhydrous, maize starch, crospovidone, ammonium calcium alginate, talc, magnesium stearate.

What this Lariam looks like and contents of the pack

Lariam tablets are White to off-white round tablets, cross scored and imprinted with ROCHE on one side.

Avaliable in blister pack of 8 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by F Hoffmann-LA Roche AG, Grenzacherstrasse 124, B93, R6.59, Basel CH-4070, Switzerland and is procured from within the EU. Product Licence Holder LTT Pharma Limited, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.

|POM| pl 33723/0165 Lariam 250mg Tablets

Lariam is a registered trademark of Roche products Limited Revision date: 27/02/14

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Other preventative actions you should take

If you are taking Lariam to prevent malaria, you should also take steps to avoid mosquito bites. Some infromation on how to avoid bites is given below. This is important as no medicine cab be 100% guaranteed to protect you against malaria.

   Make sure you sleep ina room that is screened against mosquitoes or has full air conditioning, or that you use a mosquito or has full air conditioning, or that you use a mosquito net (preferably one that has been treated with an insect repellent over the bed.

   Use insect repellents: ointments, lotions and sprays, to deter mosquitoes

   In the evening cover arms and legs with light coloured, long-sleeved clothes and trousers and use an insect repellent. Anklets are also available which have been treated with repellent

   Vaporising electric "mats” mosquito coils or tablets can be used at night-time around exposed areas of the body (ankles and feet).


Other side effects


Mefloquine 250mg Tablets

Patient Information Leaflet


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

*    Keep this leaflet. You may need to read it again.

*    If you have any further questions, ask your doctor or pharmacist.

*    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

*    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Mefloquine 250mg Tablets and will be referred to as Mefloquine throughout the rest of this leaflet.

What is in this leaflet

[4 What Mefloquine is and what it is used for 3 What you need to know before you take Mefloquine How to take Mefloquine [4 Possible side effects How to store Mefloquine [4 Contents of the pack and other information


In a small number of patients it has been shown that dizziness and loss of balance may continue for a few months after taking Mefloquine.

Mefloquine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.


^ What Mefloquine is and what it is used for

Mefloquine Tablets conatin the active ingredient mefloquine. They are used to treat malaria and to help prevent you from catching malaria.

Malaria is a life threatening disease and a major health risk for travellers visiting tropical countries.

It occurs when small parasites are passed from one person to another by the bites of certain mosquitoes. Mefloquine is especially useful if you are travelling to countries where there is a type of malaria which is particularly difficult to treat. No single medicine is effective against all malaria parasites. The choice of a particular medicine depends on the sensitivity of the malaria parasites found in the area to be visited. Your doctor will advise you whether Mefloquine is suitable for the area to which you wish to go.

To help minimise your chance of catching the disease and to protect you from possible serious side effects it is important that you read this leaflet carefully. Ask you doctor to explain anything you do not understand.


[4 What you need to know before you take Mefloquine

Do not take Mefloquine:

   if you are allergic to mefloquine or any of the other ingredients of this medicine (listed in section 6) or to similar medicines such as quinine. quinidine or chloroquine

   if you have depression, thoughts about suicide and self-endangering behaviour.

   if you have any other mental problem. including anxiety disorder, schizophrenia or psychosis (losing touch with reality)

   if you have fits (seizures or convulsions)

   if you have severe liver problems

   if you have had blackwater fever (a complication of malaria that affects the blood and kidneys)

   medicines such as quinine. quinidine. or chloroquine, used to treat or to prevent malaria

   medicines for any heart trouble, or high blood pressure, such as 3-blocking agents. calcium channel blockers

   antihistamines for allergies

   medicines for some mental problems (psychiatric disorders).

Anti—depressants such as tricyclic anti—depressants. selective serotonin reuptake inhibitors (SSRIs). bupropion or anti—psychotics such as phenothiazines

   medicines used to treat epilepsy such as sodium valproate carbamazepine, phenobarbital, phenytoin

   ketoconazole (used to treat fungal infections) — you should also ask your doctor for advice before taking ketoconazole within 15 weeks after taking Mefloquine

   antibiotics used to treat bacterial infections for example rifampicin, penecillins. cephalosporins

   efavirenz (used to treat HIV infections)

   tramadol (used to treat severe pain)

   medicines for blood clotting disorders or diabetes, as your doctor may wish to monitor you before you travel.

If you need an oral vaccine to help prevent you from catching typhoid. you should arrange to receive it at least 3 days before you need to start taking Mefloquine. Otherwise Mefloquine may stop the vaccine from working properly.

Pregnancy and breast-feeding

Pregnant women should not normally take these tablets.

It is important to tell your doctor if you are pregnant or think you could be pregnant, as she or he may decide that you should not use this medicine.

Women of child bearing age are advised to use adequate contraception whilst taking Mefloquine to prevent them from catching malaria and for 3 months after the last dose.

It is recommended that you do not breast-feed while you are taking these tablets.

Driving and using machines

Take special care if you perform activities requiring alertness and coordination (accurate small movements) and spatial awareness (being aware of distances) such as driving pilotong an aircraft, operating machinery and deep sea diving as Mefloquine can cause dizziness loss of balance and mental problems (see section 2).


rp How to take Mefloquine

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The advice you are given will depend on whether you are taking the tablets for prevention or treatment of malaria. Take the tablets with plenty of water and preferably after a meal. Swallow the tablets whole do not suck or chew them.

Malaria prevention

Please read the following section if you are taking the tablets to help prevent you from catching malaria.

If any of the above applies to you, make sure your doctor can prescribe a different medicine for prevention or treatment of malaria.

Also, consult your doctor immediately if you are already being treated with halofantrine, or you have been prescribed a course of halofantrine. Halofantrine (which is used to treat malaria) and Mefloquine taken at the same time can slow the heartbeat to a dangerous level. Therefore to help avoid the possibility of a dangerous alteration in heart rhythm you must not take halofantrine if you are already taking or have taken Mefloquine within the last 15 weeks.

Warnings and precautions

Mefloquine may cause serious mental problems in some people. Please seek medical help immediately if you experience any of the following:

   suicidal thoughts

   self-endangering behaviour

   severe anxiety

Tell your doctor if you experience any of the following:

   feelings of mistrust towards others (paranoia)

   seeing or hearing things that are not there (hallucinations)

   nightmares

   depression

   feeling restless

   unusual behaviour

   feeling confused

Talk to your doctor or pharmacist before taking Mefloquine if you:

   suffer from epilepsy

   have fits (seizures or convulsions)

   have heart problems. especially changes in heart rhythm

•    have liver or kidney problems

   have eye problems (eg loss of fine detail colours seem faded sudden loss of vision poor vision at night)

•    abnormal blood test showing a decrease or an increase in white blood cells or a decrease in red blood cells or platelets.

•    experience pins and needles, weakness numbness new or worsening clumsiness or unsteadiness on your feet, or shaking of the hands and fingers

•    experience fever, chills, cough, shortness of breath or chest pain. These could be signs of inflammation of the lungs also known as pneumonitis.

•    have previously contracted malaria even though you were taking Mefloquine tablets for malaria prevention

If you are a woman of child-bearing age you should take reliable contraceptive precautions whilst you are taking Mefloquine and for 3 months after the last dose.

Children

Experience with Mefloquine in babies less than 3 months old or weighing less than 5kg is limited.

Other medicines and Mefloquine

Tell youe doctor or pharmacist if you are taking have recently taken or might take any other medicines including:

•    haloflintrine. or you have been prescribed a course of halofantrine (see section 2)

Important

•    Take the tablets once a week always on the same day.

   Take the 1st dose 10 days before you leave: this is to make sure that lariam is well tolerated.

•    Take the 2nd dose 3 days before you leave.

•    Continue taking the tablets on the same day of the week throughout your stay and for

4 weeks after your return.

•    The full course of tablets is at least 6 weeks, depending on your length of stay.

   For effective prevention you must take the full course of tablets.

   No anti-malarial tablets can be 100% guaranteed to work. There is a chance you could still get malaria during or after taking medicine to prevent it. If you develop a fever or flu-like symptoms during your travels or within 2 to 3 months after you leave the malarious area, check with a doctor immediately.


Adults and children over 45kg body weight dose:

One tablet weekly (always on the same day):


Mefloquine 250mg Tablets


Patient Information Leaflet (continued)

A pack of 8 tablets is enough to help prevent you from catching malaria if you are staying for 2 weeks in an area where malaria is present and you start taking the tablets at 10 days and 3 days before departure.

Adults weighing less than 45kg (99 lbs) should take the childrens dose (see below).

Whether you are an adult or a child you should not take the tablets for more than 12 months.

Children's dose:

The tablets are not recommended for children under 3 months of age, i.e., those who weigh less than 5 kg (11 lbs). For children over this weight, the dose is shown in the table below. The tablets can be divided by breaking along the score lines. As in adults, the dose should be taken once weekly on the same day, and continued for 4 weeks after return.


Weight

Age

(approx)

Dose

5-19 kg (11-42 lbs)

3 months-5 years

A tablet

20-30 kg (44-66 lbs)

6-8 years

% tablet

31-45 kg (68-99 lbs)

9-14 years

% tablet


Malaria treatment

Please read the following section if you are taking the tablets to treat malaria.

Your doctor will tell you how much medicine you need to take. This will depend on your weight and whether you have been living in a malarious area. Normally, you should not receive more than 6 tablets in total. You may be advised to split the total dose into 2 or 3 smaller doses, 6-8 hours apart, to reduce the likelihood or severity of unwanted effects.

If you take more Mefloquine than you should, either for prevention or treatment

If you take too many tablets the likelihood and severity of the side effects as described in section 4 may increase.

If you take too many tablets or someone else accidentally takes your medicine contact your doctor pharmacist or nearest hospital immediately.

If you forget to take Mefloquine, either for prevention or treatment

If you miss a dose take it as soon as possible. If it is nearly time for your next dose skip the missed dose and carry on as before. Do not take a double dose.


[4 Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them.

Stop taking this medicine and contact your doctor immediately if you experience:

   attempted suicide

   suicidal thoughts

   self-endangering behaviour

   allergic reaction (anaphylaxis) with symptoms such s difficulty in breathing, swollen tongue, itching and severe rash

   severe changes in texture and appearance of the skin, especially if it affects your mouth and eyes (Stevens Johnson syndrome)

   psychosis (losing touch with reality)

   severe anxiety

   depression

   panic attacks

   fits (seizures or convulsion)

   fever, chills, cough, shortness of breath or chest pain. These could be signs of inflammation of the lungs also known as pneumonitis

   Severe liver problems which might be demonstrated by transient increase in your liver enzymes shown by blood tests or other symptoms such as tender, firm or possibly enlarged liver, jaundice (yellowing of skin/eyes), dark urine, light coloured stools and generalised itchiness

•    Pins and needles, weakness, numbness, new or worsening clumsiness or unsteadiness on your feet or shaking of the hands and fingers

   Painful mouth or throat ulcers, fever, chills, bruises on the skin, nosebleeds, bleeding in the stomach or vaginal bleeding. These could be signs of blood disorders

Talk to your doctor if you experience:

•    feelings of mistrust towards others (paranoia)

•    seeing or hearing things that are not there (hallucinations)

•    feeling restless

•    unusual behaviour

•    feeling confused

•    unusual changes in your mood

   agitation

•    new or worsening feeling of anger (aggression)

   disturbance in attention

   heart problems e.g. severe changes in heartbeat, including pounding racing or skipped beats (palpitations)

Please seek medical help immediately if you experience serious mental problems while taking Mefloquine. Mefloquine should be stopped immediately and replaced with another medicine to prevent malaria.

Other side effects

Very common (may affect more than 1 in 10 patients):

   sleeping problems (sleepiness, unable to sleep, bad dreams)


Common (may affect up to 1 in 10 patients):

   dizziness, headache, problems with your vision, loss of balance (vertigo), feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache (abdominal pain), itching

Frequency not known (cannot be estimated from available data):

   decreased appetite, forgetfulness (sometimes lasting for more than 3 months), fainting

   difficulites in talking, cataract, blurred vision, dazzled in the evenings or other vision disturbances

   changes to your hearing including ringing in the ears or difficulty in hearing (sometimes prolonged)

   changes to blood pressure or heart rate, hot flushes, breathlessness, cough, indigestion, rash, hair loss, sweating, muscle weakness, muscle cramps, joint pains, muscle pains, oedema, chest pain, tiredness, fever or chills

Mefloquine can stay in the body for a long time after taking the last dose. In few people some side effects may last for a few months after they have stopped taking Mefloquine (e.g. dizziness, sleepiness).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

By reporting side effects, you help provide more information on the safety of this medicine.


How to store Mefloquine

*    Keep out of the sight and reach of children.

*    Do not store above 30°C.

*    Store in the original package.

*    If your medicine becomes discoloured or shows any other signs of deterioration, consult your pharmacist who will tell you what to do.

*    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


Contents of the pack and other infromation

What this Mefloquine contains:

The active substance in Mefloquine is Mefloquine. Each tablet contains 250mg Mefloquine

The other ingrediens are: poloxamer 3800, microcrystalline cellulose lactose anhydrous, maize starch, crospovidone, ammonium calcium alginate, talc, magnesium stearate.

What this Mefloquine looks like and contents of the pack

Mefloquine tablets are White to off-white round tablets, cross scored and imprinted with ROCHE on one side.

Avaliable in blister pack of 8 tablets.

Manufacturer and Licence Holder

This medicine is manufactured by F Hoffmann-LA Roche AG, Grenzacherstrasse 124, B93, R6.59, Basel CH-4070, Switzerland and is procured from within the EU. Product Licence Holder LTT Pharma Limited, B98 0RE and repackaged by Lexon (UK) Limited, B98 0RE.


|POM PL 33723/0165 Mefloquine 250mg Tablets Revision date: 27/02/14

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Other preventative actions you should take

If you are taking Lariam to prevent malaria, you should also take steps to avoid mosquito bites. Some infromation on how to avoid bites is given below. This is important as no medicine cab be 100% guaranteed to protect you against malaria.

   Make sure you sleep ina room that is screened against mosquitoes or has full air conditioning, or that you use a mosquito or has full air conditioning, or that you use a mosquito net (preferably one that has been treated with an insect repellent over the bed.

   Use insect repellents: ointments, lotions and sprays, to deter mosquitoes

   In the evening cover arms and legs with light coloured, long-sleeved clothes and trousers and use an insect repellent. Anklets are also available which have been treated with repellent

   Vaporising electric "mats” mosquito coils or tablets can be used at night-time around exposed areas of the body (ankles and feet).